Experienced Clinical Research Associate Service

Benefits

Qualifications

• •May perform investigational product (IP) inventory, reconciliation and reviews storage and security
• •Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re) labelled, imported and released/returned
• •Must be able to quickly adapt to changing priorities to achieve goals / targets

Responsibilities

• •Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
• •Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• •Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• •Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
• •Demonstrates diligence in protecting the confidentiality of each subject/patient
• •Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• •Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
• •Assesses site processes
• •Conducts Source Document Review of appropriate site source documents and medical records
• •Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• •Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• •Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• •Verifies site compliance with electronic data capture requirements
• •Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• •Verifies issues or risks associated with blinded or randomized information related to IP
• •Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
• •Reconciles contents of the ISF with the Trial Master File (TMF)
• •Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• •Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
• •Supports subject/patient recruitment, retention and awareness strategies
• •Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• •For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
• •May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate
• •Ensures all assigned sites and project-specific site team members are trained and compliant with…
• •21 more items(s)